摘要
目的考察治疗性双质粒HBV DNA疫苗制剂A、B的稳定性。方法按照《中国药典》三部(2010版)方法,对治疗性双质粒HBV DNA疫苗制剂A、B分别进行影响因素试验、加速试验、长期试验,在不同条件下考察样品的基本性状,特别检测质粒DNA的超螺旋比例及进行细胞学转染试验和体内药效学试验。结果双质粒HBV DNA疫苗制剂在破坏性因素的影响下,于光照(4 500±500)Lx、高温(40和60℃)、反复冻融(-20℃←→4℃和-20℃←→RT)条件下5 d均不稳定;匀速振动(140和240 r/min)10 d不稳定;在(25±2)℃、相对湿度(60±10)%的条件下放置1个月不稳定;在温度2~8℃条件下放置2年保持稳定。结论双质粒HBV DNA疫苗制剂对光照、温度敏感,应避光低温保存,避免反复冻融,适合现代快速长途运输,长期保存应在2~8℃条件下,暂定二年有效期,为治疗性双质粒HBV DNA疫苗的临床用样品的运输和保存提供了依据。
Objective To investigate the stability of preparations A and B of therapeutic double plasmid HBV DNA vaccine. Methods According to the requirements in Chinese Pharmacopoeia（Volume Ⅲ, 2010 edition）, the preparations A and B of therapeutic double plasmid HBV DNA vaccine were subjected to influencing factor test, accelerated stability test and long-term stability test, investigation on basic character under various conditions, determination of proportion of supercoiled plasmid, as well as tests for in vitro transfection ability and in vivo pharmacodynamics. Results The preparations were unstable after storage at illumination [（4 500 ± 500） Lx], high temperature（40 and 60 ℃）, repeat freeze-thawing（-20 ℃←→4 ℃ and-20 ℃←→RT）for 5 d, after uniform vibration（140 and 240 r/min）for 10 d, and after storage at（25 ± 2） ℃ and a relative humidity of（60 ± 10）% for one month. However, the preparations were stable after storage at 2 ~ 8 ℃ for 2 years. Conclusion Therapeutic double plasmid HBV DNA vaccine was sensitive to illumination and temperature, which should be stored at low temperature, prevented from light. The vaccine was suitable for rapid long-distance transport, of which the validity period was defined as 2 years tentatively after storage at 2 - 8 ℃. It provided a basis for the transport and storage of samples of therapeutic double plasmid HBV DNA vaccine for clinical application.
作者
石燕飞
饶桂荣
黄彬
杨富强
陈光明
SHI Yan-fei RAO Gui-rong HUANG Bin YANG Fu-qiang CHEN Guang-ming(PLA Liver Disease Research Center, The 458th Hospital of PLA, Guangzhou 510600, Guangdong Province, China)
出处
《中国生物制品学杂志》
CAS
CSCD
2017年第1期43-48,共6页
Chinese Journal of Biologicals
基金
广东省科技计划项目(2015A010107011)
